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NCT05839652 Clinical Trial

Treatment of Orthostatic Hypotension in SCI

Hypotension Clinical Trial

— SCI  

Official title:
Treatment of Orthostatic Hypotension in Individuals With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05839652
Other study ID # 1747301-1
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 1, 2023
Est. completion date June 30, 2026

Study information
Verified date April 2023
Source James J. Peters Veterans Affairs Medical Center
Contact Matt G. Maher, MS
Phone 9733243588
Email matt.maher@va.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - traumatic spinal cord injury - at least 12 months post injury - injury level of C1-T6 - AIS A, B or C - non-ambulatory - non-ventilator Exclusion Criteria: - Active psychiatric disorder - Stroke or cerebrovascular disease - Alzheimer's Disease or dementia - Unmanaged cardiac arrhythmias - Concurrent systemic, hepatic, or renal disease - Suspected or diagnosed malignancy - Neurological disease other than SCI - Self-reported history of three or more symptomatic episodes of AD per day

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Midodrine Hydrochloride
Determine best drug and dose to increase and stabilize SBP during orthostatic tilt

Locations
Country Name City State
United States James J Peters VA Medical Center Bronx New York
United States Kessler Foundation West Orange New Jersey

Sponsors (2)
Lead Sponsor Collaborator
James J. Peters Veterans Affairs Medical Center Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systolic blood pressure determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo 3 years
Secondary Cerebral blood flow velocity determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo 3 years
Secondary Symptoms of autonomic dysreflexia and orthostatic hypotension determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo 3 years
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